Phase II Study for the Evaluation of CPT-11 (Irinotecan, Camptosar) in Patients With Metastatic or Recurrent Breast Cancer

Trial Information

Phase II Study for the Evaluation of CPT-11 (Irinotecan, Camptosar) in Patients With Metastatic or Recurrent Breast Cancer

OBJECTIVES: I. Determine the objective response rate to irinotecan in patients with metastatic breast cancer who have received prior anthracycline and taxane based chemotherapy for metastatic disease. II. Determine the toxicities of irinotecan in these patients. III. Determine survival time, duration of response, and time to treatment failure in these patients after this therapy.

OUTLINE: Patients receive irinotecan IV over 90 minutes weekly for 4 weeks. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed at day 30, then every 3 months.

PROJECTED ACCRUAL: A total of 14-29 patients will be accrued for this study.

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